Job Description

Responsibilities

  • Perform release test as per procedure.
  • Perform Lab tests, calculations and necessary reviewing of Lab records.
  • Timely report lab issues of any case and ensure GMP compliance.
  • Timely document the observations in case of Lab event, OOX and deviations and involve in the investigations if necessary.
  • Involve the update the lab procedure, ensure execution.
  • Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.
  • Proactively study regulatory documents from various countries, such as BP, USP, JP, and EP, and refer to these documents when updating internal procedures.
  • Participate in customer audits and government inspections, promptly address identified issues, and ensure GMP compliance.
  • Timely track work progress, strengthen communication with internal and external clients, and establi...

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